Incoming Inspections Lead: Quality & Compliance SME

Guerbet; Raleigh (NC); On-site; USD 85,000 - 125,000; Full time

Job summary

Guerbet is seeking an Incoming Inspections Lead in Raleigh, NC to ensure raw materials, components, and packaging meet strict specs before release. The role requires deep knowledge of cGMP and regulatory expectations and hands-on leadership of the inspection team.

You will serve as SME for incoming inspections during FDA/EMA audits, coach analysts, and drive continuous improvement across QA, Procurement, Manufacturing and Regulatory Affairs to maintain compliant supply.

Qualifications

• Bachelor’s degree and 5+ years in incoming inspection in cGMP.
• Experience with cGMP, USP, sampling plans and specs.
• Proven investigations, qualification, and supplier issues.
• Strong leadership and cross-functional communication.

Responsibilities

• Leads and owns the incoming inspection program, ensuring materials meet specifications and regulatory requirements prior to release for use.
• Serves as Subject Matter Expert (SME) for incoming inspections during regulatory audits and inspections (e.g., FDA, EMA).
• Provides technical leadership, coaching, and mentorship to incoming inspection analysts and technicians.
• Reviews and approves incoming inspection results, documentation, specifications, and test methods.
• Ensures sampling and testing of raw materials, components, and packaging materials are performed in accordance with SOPs and compendial requirements.
• Establishes and maintains sampling plans, test methods, and acceptance criteria for incoming materials.
• Leads investigations related to incoming material non-conformance, OOS, OOT, or supplier-related quality issues, including root cause analysis and CAPA implementation.
• Drives supplier quality collaboration by supporting material qualification, supplier audits, and change notifications.
• Owns lifecycle management of incoming material specifications, including change control, periodic review, and continuous improvement.
• Ensures laboratory equipment and systems used for incoming inspections are qualified, calibrated, and maintained in an audit-ready state.
• Ensures compliance with cGMP, USP, and internal quality standards, including data integrity (ALCOA+) principles.
• Collaborates cross-functionally with QA, Procurement, Manufacturing, Warehouse, and Regulatory Affairs to support material release and supply chain continuity.
• Leads or contributes to continuous improvement initiatives to enhance inspection efficiency, effectiveness, and compliance.
• Oversees training and ensures competency of personnel performing incoming inspections.
• Performs other duties as assigned by management.

Skills

Leadership

Communication

Problem solving

Cross-functional

Education

Bachelor’s degree or equivalent

Tools

LIMS

SAP ERP

ALCOA+

Job description

Guerbet is seeking an Incoming Inspections Lead in Raleigh, NC to ensure raw materials, components, and packaging meet strict specs before release. The role requires deep knowledge of cGMP and regulatory expectations and hands-on leadership of the inspection team.

You will serve as SME for incoming inspections during FDA/EMA audits, coach analysts, and drive continuous improvement across QA, Procurement, Manufacturing and Regulatory Affairs to maintain compliant supply.